Working... Menu

Treatment of Hyperglycaemia and Insulin Resistance in HIV Infected Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00483392
Recruitment Status : Completed
First Posted : June 7, 2007
Last Update Posted : June 7, 2007
Information provided by:
University Medical Centre Ljubljana

Brief Summary:
The purpose of this study is to evaluate and compare the effects of treatment with rosiglitazone and metformin on insulin resistance in patients infected with Human Immunodeficiency Virus on stable Highly Active Antiretroviral Therapy including a Protease Inhibitor after the period of 48 weeks.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: metformin, rosiglitazone Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. fasting plasma glucose, basal insulin levels [ Time Frame: 48 weeks ]

Secondary Outcome Measures :
  1. insulin resistance, beta cell function [ Time Frame: 48 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male

Inclusion Criteria:

  • documented HIV infection
  • stable Protease Inhibitor containing HAART regimen for at least 12 months
  • impaired glucose tolerance
  • elevated insulin levels (above 20 mIU/l)

Exclusion Criteria:

  • patients already taking oral hypoglycaemic treatment or insulin
  • heart failure NYHA I-IV
  • liver disease or kidney disease
  • elevated AST or ALT above 2 times upper normal range
  • elevated creatinine (above 150 mmol/l)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00483392

Layout table for location information
Department of Endocrinology, Diabetes and Metabolic diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Layout table for investigator information
Study Chair: Andrej Janez, MD, PhD Department of Endocrinology, Diabetes and Metabolic Diseases, Medical Center Ljubljana, Zaloska 7, 1525 Ljubljana, Slovenia

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00483392     History of Changes
Other Study ID Numbers: J3-3545
Slovenia grant J3-3545
First Posted: June 7, 2007    Key Record Dates
Last Update Posted: June 7, 2007
Last Verified: June 2007

Keywords provided by University Medical Centre Ljubljana:
protease inhibitors

Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs